8 TECH OUTLOOKMarch - 2018Working toward Personalized and Precision MedicineBy Pranil Chandra, VP & CMO, Genomic and Clinical Pathology Services, PathGroupGenomic research holds the key to many of today's health challenges. Scientists have come a long way since the human genome project, identifying upwards of 2,000 genes, to an era where genomic principles are applied to the practice of medicine, specifically in pathology and the laboratory. However, that is just the tip of the iceberg and there are various challenges to realizing the promise of precision oncology and personalized medicine.Clinical Management of PatientsThere are many opportunities for patients to utilize genomic testing services, which inform a combination of diagnosis, prognosis, and therapy. Yet, there are many barriers regarding payment for such services, since payers are not always supportive of reimbursing molecular testing. Academic research aimed at discovering game-changing breakthroughs has met with difficulty translating into clinically useful diagnostic tests. Although molecular testing is considered a standard of healthcare by national authorities and high-impact publications, the Centers for Medicare & Medicaid Services and other insurance payers do not provide coverage for many molecular tests. Also, the Food and Drug Administration expressed interest in regulating molecular testing, but realized that it was a resource-intensive process and acknowledged that current practices, regulated under CLIA, ensure validation and deployment of high quality molecular and genomic assays.Payers are narrowly focused on therapeutic applications of molecular testing, and there is a need to better define clinical utility which entails not only therapeutic prediction but also involves the total clinical management of patients. Payers will, hopefully, soon realize that leveraging genomic testing tools IN MY OPINIONPranil Chandra
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